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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0405765 地氯雷他定糖浆 desloratadine Oral solution Chemical Drugs(5) New Drug Application 2004-10-14 北京德众万全医药科技有限公司 Beijing Dezhong Wanquan Medicine Technology Co Ltd Certificate Issued 2005-04-29 view
X0405026 地氯雷他定枸橼酸氢二钠片 desloratadine citrate disodium Tablet Chemical Drugs(4) New Drug Application 2004-09-05 合肥医工医药有限公司 Hefei Medical and Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
X0405025 地氯雷他定枸橼酸氢二钠胶囊 desloratadine citrate disodium Capsule Chemical Drugs(4) New Drug Application 2004-09-05 合肥医工医药有限公司 Hefei Medical and Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
X0405024 地氯雷他定枸橼酸氢二钠 desloratadine citrate disodium Active ingredient Chemical Drugs(4) New Drug Application 2004-09-05 合肥医工医药有限公司 Hefei Medical and Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
X0402737 地氯雷他定口腔崩解片 desloratadine Tablet Chemical Drugs(5) New Drug Application 2004-05-31 海南普利制药有限公司 Hainan Poly Pharm Co Ltd;Hangzhou Saili Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-12-31 view
X0402256 地氯雷他定片 desloratadine Tablet Chemical Drugs Supplementary Application 2004-04-28 海南普利制药有限公司 Hainan Poly Pharm Co Ltd Certificate Issued 2004-08-09 view
X0402128 地氯雷他定糖浆 desloratadine Oral solution Chemical Drugs(5) New Drug Application 2004-04-23 深圳市海滨制药有限公司 Shenzhen Haibin Pharmaceutical Co Ltd Certificate Issued 2005-05-13 view
X0401967 地氯雷他定分散片 desloratadine Tablet Chemical Drugs(5) New Drug Application 2004-04-19 深圳市海滨制药有限公司 Shenzhen Haibin Pharmaceutical Co Ltd Certificate Issued 2005-08-10 view
X0401966 地氯雷他定干混悬剂 desloratadine Suspension Chemical Drugs(5) New Drug Application 2004-04-19 海南普利制药有限公司 Hainan Poly Pharm Co Ltd;Hangzhou Saili Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-08-16 view
X0400633 地氯雷他定口腔崩解片 desloratadine Tablet Chemical Drugs(5) New Drug Application 2004-09-13 深圳市海滨制药有限公司 Shenzhen Haibin Pharmaceutical Co Ltd;Weidakang Biomedical Technology (Shenzhen) Co Ltd Certificate Issued 2005-01-14 view
X0304285 地氯雷他定 desloratadine Active ingredient Chemical Drugs Supplementary Application 2003-08-20 深圳市海滨制药有限公司 Shenzhen Haibin Pharmaceutical Co Ltd Certificate Issued 2003-12-30 view
X0304275 地氯雷他定片 desloratadine Tablet Chemical Drugs Supplementary Application 2003-08-20 深圳市海滨制药有限公司 Shenzhen Haibin Pharmaceutical Co Ltd Certificate Issued 2003-12-30 view
X0303833 地氯雷他定口腔崩解片 desloratadine Tablet Chemical Drugs(5) New Drug Application 2003-08-06 海南普利制药有限公司 Hainan Poly Pharm Co Ltd;Hangzhou Saili Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-07-19 view
X0302931 地氯雷他定糖浆 desloratadine Oral solution Chemical Drugs(5) New Drug Application 2003-06-17 北京卫信康医药科技有限公司 Beijing Weixinkang Medical Technology Co Ltd Certificate Issued 2004-01-14 view
X0302520 地氯雷他定干混悬剂 desloratadine Suspension Chemical Drugs(5) New Drug Application 2004-03-11 北京卫信康医药科技有限公司 Beijing Weixinkang Medical Technology Co Ltd Certificate Issued 2004-07-05 view
X0302262 地氯雷他定口腔崩解片 desloratadine Tablet Chemical Drugs(5) New Drug Application 2004-10-11 北京卫信康医药科技有限公司 Beijing Weixinkang Medical Technology Co Ltd Certificate Issued 2005-07-15 view
X0301462 地氯雷他定片 desloratadine Tablet Chemical Drugs Supplementary Application 2003-03-26 深圳信立泰药业有限公司 Shenzhen Salubris Pharmaceuticals Co Ltd Certificate Issued 2003-09-19 view
X0301458 地氯雷他定 desloratadine Active ingredient Chemical Drugs Supplementary Application 2003-03-26 深圳信立泰药业有限公司 Shenzhen Salubris Pharmaceuticals Co Ltd Certificate Issued 2003-09-19 view
X0300066 地氯雷他定片 desloratadine Tablet Chemical Drugs Supplementary Application 2003-01-17 海南普利制药有限公司 Hainan Poly Pharm Co Ltd Certificate Completed-Pending Issued 2003-03-30 view
JYHZ2300109 地氯雷他定片 desloratadine Tablet Chemical Drugs License Renew 2023-03-02 N V Organon;Oujialong (Shanghai) Pharmaceutical Technology Co Ltd;Schering-Plough Labo NV view